Scleroderma (Systemic Sclerosis) and Haematopoietic stem-cell transplantation (HSCT): what the trial registry contains
The ClinicalTrials.gov registry holds 24 records for HSCT in Scleroderma (Systemic Sclerosis): 3 recruiting now, 4 labelled Phase 3 or 4, across 7 countries. Snapshot 2026-08-29.
Why this is studied in Scleroderma (Systemic Sclerosis)
Systemic sclerosis combines vascular injury, autoimmunity and progressive fibrosis of skin and internal organs. Autologous haematopoietic transplantation has controlled trial evidence in severe rapidly progressive disease — with real treatment-related mortality — making this an indication where risk-benefit must be stated explicitly rather than implied.
What HSCT means in this table
Haematopoietic transplantation is the oldest and most consequential cell therapy in medicine, with conditioning regimens that carry real mortality risk alongside genuine disease-modifying power. Registrations under this label therefore mix decades-old standard-of-care protocols with newer autoimmune-reset trials, and the risk profile is nothing like that of an outpatient infusion.
The numbers
Every figure below comes from one reproducible query (systemic sclerosis x hematopoietic stem cell transplantation) run against ClinicalTrials.gov API v2 on 2026-08-29.
| Metric | Value |
|---|---|
| Registered studies (all statuses) | 24 |
| Interventional studies in the sample | 21 |
| Recruiting right now | 3 |
| Completed | 10 |
| Terminated, withdrawn or suspended | 7 |
| Phase 3 or Phase 4 records | 4 |
| Countries with at least one site | 7 |
| Median planned enrolment | 20 participants |
| Largest single planned enrolment | 82 participants |
| First / most recent start year | 1999 — 2026 |
How mature is this evidence?
The field has produced some later-stage designs — 4 of the 24 records carry a Phase 3 or 4 label — but the bulk of activity remains earlier-phase safety and signal-finding work.
Completion status: 10 completed, 7 stopped early (29% of all records). A registration is a plan, not a result.
| Phase label | Records | Share |
|---|---|---|
| Phase 2 | 13 | 46% |
| Phase 1 | 7 | 25% |
| Phase 3 | 3 | 11% |
| Not applicable | 3 | 11% |
| Early Phase 1 | 1 | 4% |
| Phase 4 | 1 | 4% |
Median planned enrolment is 20 participants (largest single study: 82). Trials of this size can describe safety and generate hypotheses; detecting a modest clinical benefit reliably usually needs substantially larger numbers with a control group.
Where the studies are
Sites are spread across 7 countries, with United States accounting for roughly 69% of country mentions — geography reflects where regulators permit this work and where sponsors sit, not where care is best.
| Country | Studies with a site there |
|---|---|
| United States | 18 |
| France | 2 |
| Canada | 2 |
| Germany | 1 |
| Italy | 1 |
| Netherlands | 1 |
| United Kingdom | 1 |
Legal pathway differs by country — see where cell therapy is legal, by country.
Who runs them
Sponsorship leans academic: 6 of the most frequent lead sponsors read as academic or hospital entities and 5 as companies. Who pays shapes what gets measured and what gets published.
- Fred Hutchinson Cancer Center — 3 records
- Northwestern University — 3 records
- European Society for Blood and Marrow Transplantation — 2 records
- Baylor College of Medicine — 1 record
- University Hospital Tuebingen — 1 record
- Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium — 1 record
Representative registered studies
Recruiting studies first, then the most advanced phases. Each identifier links to the registry record, where eligibility criteria, outcome measures and contacts are published.
| Study | Phase | Status | Planned n | Lead sponsor | Start |
|---|---|---|---|---|---|
| NCT05029336 — Autologous Stem Cell Transplant (ASCT) for Autoimmune Diseases | Phase 2 | Recruiting | 20 | Stephan Grupp MD PhD | 2026-03 |
| NCT06619561 — A Study to Evaluate Vimseltinib in Adults With Active Chronic Graft-Versus-Host Disease (cGVHD) | Phase 2 | Recruiting | 48 | Deciphera Pharmaceuticals, LLC | 2024-11-21 |
| NCT03630211 — Autologous Stem Cell Transplantation in Patients With Systemic Sclerosis | Phase 2 | Recruiting | 8 | Paul Szabolcs | 2018-07-31 |
| NCT04380831 — TBI Using IMRT and Cyclophosphamide Prior to Stem Cell Transplant for the Treatment of Severe Systemic Sclerosis | Early Phase 1 | Active Not Recruiting | 15 | City of Hope Medical Center | 2022-02-24 |
| NCT04464434 — Upfront Autologous HSCT Versus Immunosuppression in Early Diffuse Cutaneous Systemic Sclerosis | Phase 4 | Completed | 60 | UMC Utrecht | 2020-09-17 |
| NCT03593902 — Cardiac Safe Transplants for Systemic Sclerosis | Phase 2, Phase 3 | Terminated | 9 | Northwestern University | 2018-05-17 |
| NCT01445821 — Autologous Stem Cell Systemic Sclerosis Immune Suppression Trial | Phase 3 | Terminated | 44 | Northwestern University | 2011-09-15 |
| NCT00114530 — Scleroderma: Cyclophosphamide or Transplantation | Phase 2, Phase 3 | Completed | 75 | National Institute of Allergy and Infectious Diseases (NIAID | 2005-06 |
| NCT07734012 — Mycophenolate After Stem Cell Transplant for Systemic Sclerosis | Phase 2 | Not Yet Recruiting | 6 | Ottawa Hospital Research Institute | 2026-08 |
| NCT05098145 — A Safety and Efficacy Study of FCR001 in Adults With Rapidly Progressive Diffuse Cutaneous Systemic Sclerosis | Phase 1, Phase 2 | Withdrawn | n/a | Talaris Therapeutics Inc. | 2021-11-24 |
What this page does and does not tell you
A registry is a plan repository. Counting entries tells you what people intended to study, which is a weaker thing than what they found.
If a clinic offers you this today, the useful question is not "is there research?" but "which of these registered studies is mine part of, and if none, what evidence applies to the exact product I am being sold?" The Provider Question Builder turns that into a scored checklist.
Frequently asked
How many HSCT studies for Scleroderma (Systemic Sclerosis) are recruiting right now?
3 of 24 registered records were listed as recruiting in the 2026-08-29 snapshot. Recruitment status changes frequently; the registry record is authoritative.
Is HSCT an approved treatment for Scleroderma (Systemic Sclerosis)?
Registration on ClinicalTrials.gov is not approval. Approval is granted by a regulator for a specific product and indication after review of submitted evidence. 24 registered studies tell you research exists, not that a product cleared review.
How advanced is the research on HSCT for Scleroderma (Systemic Sclerosis)?
4 of 24 records carry a Phase 3 or Phase 4 label and 10 are marked completed. Registrations run from 1999 to 2026.
Registry and literature counts retrieved 2026-08-29 (ClinicalTrials.gov API v2; PubMed E-utilities). Registration or publication volume measures research activity, not effectiveness or approval. Educational information — not medical advice; verify product, indication, legal pathway and evidence with an independent qualified physician. Page generated 2026-08-29. See our editorial standards.
More on this condition
- Scleroderma (Systemic Sclerosis): cell-therapy evidence and registered trials
- How much does stem cell therapy for Scleroderma (Systemic Sclerosis) cost? (2026)
- Scleroderma (Systemic Sclerosis) stem cell therapy — your questions answered (2026)
- Scleroderma (Systemic Sclerosis): cell-therapy evidence by therapy class
- MSC vs HSCT for Scleroderma (Systemic Sclerosis): what the registries show
Download the query data
Query totals are full API matches; status, phase and country counts describe the first up to 400 returned records per query. Query classes overlap and must not be summed as unique trials. Counts are not treatment outcomes. Snapshot: 2026-08-29. Methods and field definitions.